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You’ll need to design and implement an FDA regulatory strategy that plans ahead for key reimbursement decisions. Seven Steps to Successful Medical Device Reimbursement explains:
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- How to evaluate the 510(k)/PMA options in terms of maximizing reimbursement
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- What are key reimbursement questions that must be asked in advance of selecting the FDA approval pathway
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- How to decide what data is needed to support both a favorable FDA outcome and obtain the desired reimbursement
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- How to comply with FDA labeling requirements and assess its impact on reimbursement
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- When to apply for a new code or when to seek coding confirmation (how not to shoot your company in the foot with premature reimbursement efforts)
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- What you can say at launch about reimbursement
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- The most important websites to access national and local reimbursement policies
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Experts Steve Terman and Gordon Schatz walk you through seven key steps to strategically blend reimbursement and FDA regulatory issues. The seven steps include:
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Choose the clearance pathway — 510(k), Premarket Approval or De Novo — that is most likely to lead you to long-term reimbursement success
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Start early in the development process so you have time to coordinate
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Identify key opinion leaders who can partner you through the payer dialogue
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Take a hard look at your product’s value and determine your reimbursement goals
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Decide on the outcomes data you’ll need to make your case to payers
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Coordinate your coding, coverage and payment strategies
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Plan to monitor and re-engage with payers every year as coding, coverage and payments change
Order your copy of Seven Steps to Successful Medical Device Reimbursement for an overview of the regulatory and reimbursement processes and how they fit together.
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- CEO, CFO, CMO, VP RA/QA, Marketing/Sales
- Regulatory Affairs
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- Marketing, Sales and Product management
- Reimbursement
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